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Comparison of Oral Lactulose Versus Polyethylene Glycol for Bowel Preparation

NCT04794049 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 800

Last updated 2021-03-11

No results posted yet for this study

Summary

Adequate quality of bowel preparation(BP) is essential for colonoscopy. Several guidelines recommend that split-dose of 4L PEG should be used as a standard regime for BP. However, the high-volume PEG caused lower compliance to the regime and increased cost.

Oral lactulose is a treatment for constipation. It tastes sweet and has no obvious gastrointestinal side effects. Previous study shows 200ml lactulose oral solution plus 2L water has been proven superior BP compared to 2L PEG. However, there is a lack of research describing bowel cleansing and colonoscopy outcomes using lactulose oral solution compared with the standard split dose of 4L PEG. Here we compared the use of a lactulose oral solution (300ml+1.5 L) with a PEG formulation (2 L) for colonoscopy preparation using the following metrics: quality of cleansing, colonoscopy outcomes, patient/physician satisfaction, and patient tolerability.

Conditions

  • Colon Disease

Interventions

DRUG

Lactulose

In experiment cohort, patients do not use standard bowel preparation regimen, they totally drink 300ml lactulose.

DRUG

Polyethylene Glycol (PEG)

In control cohort, patients use the standard split-dose bowel preparation regimen,

Sponsors & Collaborators

  • First People's Hospital of Hangzhou

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
SCREENING
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-05-01
Primary Completion
2021-10-30
Completion
2021-12-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04794049 on ClinicalTrials.gov